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FDA 510(k)

EasyClip Xpress

K-Number: K162321 · 2017-02-10

ApplicantRestore Surgical, LLC Dba Instratek
Decision Date2017-02-10
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EasyClip Xpress is a medical device manufactured by Restore Surgical, LLC Dba Instratek. It received FDA 510(k) clearance on 2017-02-10 under approval number K162321. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EasyClip Xpress?

EasyClip Xpress is a medical device that received FDA 510(k) clearance on 2017-02-10. It is manufactured by Restore Surgical, LLC Dba Instratek. The 510(k) number is K162321.

When was EasyClip Xpress approved by the FDA?

EasyClip Xpress received FDA 510(k) clearance on 2017-02-10, under approval number K162321.

What company makes EasyClip Xpress?

EasyClip Xpress is manufactured by Restore Surgical, LLC Dba Instratek.

What is the FDA product code for EasyClip Xpress?

The FDA product code for EasyClip Xpress is JDR.

Other Devices by Restore Surgical, LLC Dba Instratek

K161778ToeTac™ 10° Hammertoe Fixation System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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